Back to resultsPharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Primary Purpose
Gastroparesis, Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Immediate-release omeprazole
Delayed-release omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Gastroesophageal reflux disease, heartburn
Eligibility Criteria
Inclusion Criteria:
- Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning feeling rising from the stomach or lower chest up towards the neck"
- Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation.
- Prior abnormal 4-hour gastric emptying scan within the past 3 years
Exclusion Criteria:
- History of esophageal or gastric surgery
- Severe gastroparesis with any of the following: vomiting with dehydration requiring IV hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding jejunostomy tubes
- Presence of gastric electrical stimulator
- Symptoms of retching with vomiting more than 2 days per week
- Diagnosis of diabetes
- Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)
- Disorders of small bowel absorption
- Diagnosis of gastric outlet, small bowel or colon mechanical obstruction
- Diagnosis of acid hypersecretory syndrome
- Disorders affecting proton pump inhibitor metabolism (such as liver failure)
- Known allergy or side effects to proton pump inhibitor
- Non-ambulatory patients: bed-ridden, nursing home resident, etc.
- Pregnancy
Sites / Locations
- Digestive Health Center, University of Louisville Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate-release omeprazole release first
Delayed-release omeprazole first
Arm Description
subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
Outcomes
Primary Outcome Measures
Time to Maximal Omeprazole Concentration (Tmax)
Time to max concentration for Immediate release vs. Delayed release omeprazole
Maximal Concentration of Omerazole
Maximal concentration of immediate-release vs. delayed-release omeprazole
Area Under the Curve for Omeprazole Plasma Concentration
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
Secondary Outcome Measures
Full Information
NCT ID
NCT00492622
First Posted
June 26, 2007
Last Updated
June 29, 2017
Sponsor
University of Louisville
Collaborators
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00492622
Brief Title
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Official Title
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
Collaborators
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.
Detailed Description
Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot.
Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis.
Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Gastroesophageal Reflux Disease
Keywords
Gastroparesis, Gastroesophageal reflux disease, heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate-release omeprazole release first
Arm Type
Experimental
Arm Description
subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
Arm Title
Delayed-release omeprazole first
Arm Type
Experimental
Arm Description
subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
Intervention Type
Drug
Intervention Name(s)
Immediate-release omeprazole
Intervention Description
Immediate-release omeprazole 40 mg qam for 7 days
Intervention Type
Drug
Intervention Name(s)
Delayed-release omeprazole
Intervention Description
Delayed-release omeprazole 40 mg qam for 7 days
Primary Outcome Measure Information:
Title
Time to Maximal Omeprazole Concentration (Tmax)
Description
Time to max concentration for Immediate release vs. Delayed release omeprazole
Time Frame
10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment
Title
Maximal Concentration of Omerazole
Description
Maximal concentration of immediate-release vs. delayed-release omeprazole
Time Frame
10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment
Title
Area Under the Curve for Omeprazole Plasma Concentration
Description
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
Time Frame
0 to 5 hrs after the study drug was ingested on treatment day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning feeling rising from the stomach or lower chest up towards the neck"
Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation.
Prior abnormal 4-hour gastric emptying scan within the past 3 years
Exclusion Criteria:
History of esophageal or gastric surgery
Severe gastroparesis with any of the following: vomiting with dehydration requiring IV hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding jejunostomy tubes
Presence of gastric electrical stimulator
Symptoms of retching with vomiting more than 2 days per week
Diagnosis of diabetes
Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)
Disorders of small bowel absorption
Diagnosis of gastric outlet, small bowel or colon mechanical obstruction
Diagnosis of acid hypersecretory syndrome
Disorders affecting proton pump inhibitor metabolism (such as liver failure)
Known allergy or side effects to proton pump inhibitor
Non-ambulatory patients: bed-ridden, nursing home resident, etc.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Wo, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Health Center, University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19925497
Citation
Wo JM, Eversmann J, Mann S. Pharmacokinetic profile of immediate-release omeprazole in patients with gastro-oesophageal reflux associated with gastroparesis. Aliment Pharmacol Ther. 2010 Feb 15;31(4):516-22. doi: 10.1111/j.1365-2036.2009.04203.x. Epub 2009 Nov 19.
Results Reference
result
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Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
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